Kornimate/medical-research-clean huggingface dataset:
a study to evaluate immunity to varicella zoster virus after immunization with v212 vaccine or zostavax (v212-003)

Conditions: Herpes Zoster

Summary: a study in two parts (part a and part b) to evaluate the responsiveness of various biomarkers of immunity to varicella-zoster virus (vzv) following repeated immunizations with heat treated vzv vaccine v212 or with zostavax™. the enrollment of participants into this study was conducted in 2 parts, part a and part b. the first 42 eligible participants were enrolled into part a of the study. in part a, the reaction of the vzv skin test at baseline was evaluated at both 48 and 72 hours post administration of the vzv skin test reagent and saline (in opposite arms), with 2 examiners performing the reading at each timepoint; all subsequent skin test readings in part a were performed at 48 hours post administration. after all skin test reactions were obtained at baseline for the 42 subjects in part a, an interim analysis was performed (1) to assess the frequency of baseline negative skin tests in order to confirm that the planned sample size (n=120) was adequate for an evaluation of the effect of vaccination on the vzv skin test, and (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours (post administration) in order to determine the preferred time for evaluation of the skin test reaction. the interim analysis from part a confirmed the study sample size, an additional 78 subjects were enrolled into part b to achieve the planned sample size (n=120). the study procedures for part b of the study were identical to those in part a with the following exceptions: (1) baseline skin test readings were performed only once, at either 48 or 72 hours (post administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was needed for the skin test reading at baseline.

all eligible participants, regardless of treatment group, were administered three injections of the varicella antigen (vzv skin test reagent), once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination. reactions to the skin test were assessed by the same examiner for each participant to the greatest extent possible.

Eligibility criteria:
inclusion criteria: * participant has prior history of varicella * female participants are of non-childbearing potential exclusion criteria: * participant has had a hypersensitivity reaction to any vaccine component * participant has a prior history of herpes zoster * participant has received any varicella or zoster vaccine including zostavax * participant has a history of immunosuppression caused by disease, corticosteroids, cancer therapy or organ transplant * participant has an active cancer * participant has received or will receive a live virus vaccine or an inactivated virus vaccine 4 weeks prior to participating in study (with the exception of influenza vaccine) * participant is not bed-ridden or homebound
pre-procedure planning for radiofrequency ablation using ct or mr/us fusion

Conditions: Liver Cancer

Summary: the purpose of this study is to determine whether fusion technique of pre-radiofrequency ablation (rfa) cross-sectional imaging (ct or mr) and real-time ultrasonography would improve feasibility of rfa in patients with liver tumor in comparison with ultrasonography guidance alone.

rfa is one of commonly used local therapies for primary or secondary liver tumors. for successful and safe procedure, safe route of electrode and lesion visibility are essential for rfa, and the conditions are usually evaluated on pre-rfa planning ultrasonography (usg). however, rfa is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . therefore, precise targeting and assuring safe route would be of clinical importance. in this preliminary study, investigators attempted to determine us and ct/mr fusion technique would be able to improve rfa feasibility in patients with liver tumors in comparison with conventional us alone technique.

Eligibility criteria:
inclusion criteria: all conditions should be satisfied for inclusion. * referred to radiology in our institution for liver tumor rfa * available pre-rfa liver ct or liver mr imaging within 6 weeks exclusion criteria: patients with any of following condition should be excluded. * any contraindication of liver rfa * any patients who received treatment between pre-rfa imaging and planned rfa * patients referred for palliative purpose.

Keywords: ablation fusion
acute lung injury after aortic valve surgery

Conditions: Lung Injury

Summary: the purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by cpb in aortic valve surgery. study questions: * is there any correlation between the release of pro-inflammatory biomarkers and lung injury degree? * is there any correlation between oxyhaemodynamic parameters and lung injury degree? * is there any correlation between oxyhaemodynamic parameters and the release of pro-inflammatory biomarkers? * are budesonide, erdostein and acetylcystein effective in the prevention of lung injuries?


Eligibility criteria:
inclusion criteria: * elective aortic valve surgery patient * written consent exclusion criteria: * none

Keywords: aortic valve surgery cpb lung injury
a safety study of 3 different bowel cleansing preparations

Conditions: Colonoscopy; Bowel Preparation; Endoscopy

Summary: the objective of this study is to compare the safety, tolerance and efficacy of bli800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.


Eligibility criteria:
inclusion criteria: * male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. * at least 18 years of age * if female, and of child-bearing potential, is using an acceptable form of birth control * negative urine pregnancy test at screening, if applicable * in the investigator's judgment, subject is mentally competent to provide informed consent to participate in the study exclusion criteria: * subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. * subjects who had previous significant gastrointestinal surgeries. * subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances. * subjects with severe liver or renal insufficiency. * subjects with a history of congestive heart failure or other clinically significant cardiac abnormality. * subjects with impaired consciousness that predisposes them to pulmonary aspiration. * subjects undergoing colonoscopy for foreign body removal and decompression. * subjects who are pregnant or lactating, or intending to become pregnant during the study. * subjects of childbearing potential who refuse a pregnancy test. * subjects allergic to any preparation components * subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures. * subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Keywords: colonoscopy bowel preparation endoscopy
follow-up study to investigate the effect of gsk2245035 on nasal allergic reactivity in subjects completing treatment in study tl7116958

Conditions: Asthma and Rhinitis

Summary: this study will evaluate the duration of effect of gsk2245035 on allergic reactivity by repeating a nasal allergen challenge (nac) approximately one year after treatment in subjects from tl7116958. this is a single centre, single period study in subjects with respiratory allergy/allergies who completed the study tl7116958 in 2014 to investigate the long term effect of previous treatment with gsk2245035 compared with placebo on total nasal symptoms elicited by nasal allergen challenge. subjects and staff will remain blinded to the treatment received in the tl7116958 study (gsk2245035 or placebo). the study will consist of a screening visit to assess eligibility criteria, a study period consisting of a single visit when the nasal allergen challenge will be performed, and follow up by phone or a clinic visit at the discretion of the investigator 4-7 days following the allergen challenge. eligible subjects will participate in this study for approximately70 days total from screening to follow up.


Eligibility criteria:
inclusion criteria: * adult subjects with allergic rhinitis who completed study tl7116958 in 2014. * healthy as determined by the investigator or medically qualified designee based on a brief physical examination. * males and non-pregnant females. * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. exclusion criteria: * unresolved respiratory tract infection (rti) at the time of study visit 2 nac. investigator discretion will be used regarding rtis that have resolved during the 4 weeks preceding study visit 2. * unresolved asthma exacerbation requiring hospitalization and/or treatment with oral steroids or high doses of inhaled steroids at the time of study visit 2 nac. investigator discretion will be used regarding exacerbations that have resolved since screening visit. * a change in medical history since completion of the study tlr7116958 that in the opinion of the investigator and glaxosmithkline (gsk) medical monitor may pose additional risk factors. * subjects with a history of treatment with allergen-specific immunotherapy since completion of the tl7116958 study; subjects that have taken an investigational drug that, in the opinion of the investigator or designee, would have an effect on the nasal allergen challenge * subjects using steroid treatment (nasal steroids, 4 weeks; oral steroids, 4 weeks; inhaled steroids, 4 weeks) for allergic rhinitis and/or asthma prior to study visit 2, nasal allergen challenge * subjects using antihistamines (nasal antihistamines, 48 hours; oral antihistamines 72 hours), decongestants (nasal decongestants, 24 hours; oral decongestants, 24 hours.), prior to study visit 2, nasal allergen challenge. * subject is mentally or legally incapacitated.

Keywords: allergic rhinitis nasal allergen challenge allergic asthma effect on allergen reactivity
matrix metalloproteinases and human papillomavirus in dysplasias and cancers of the cervix

Conditions: Papillomavirus Infections; Dysplasia; Cervix Cancer

Summary: this study aims to compare the expression of matrix metalloproteinases and their tissue inhibitors between 4 groups of patients defined according to the severity of the cervical lesion.

cervical cancer is the second most common cancer among european women under 45 years old. it is secondary to cervical dysplasia induced by persistent human papillomavirus infection. the involvement of matrix metalloproteinases in carcinogenesis of the cervix is real, but their expressions vary according to the published series. an association between the expression of mmps and that of the human papillomavirus deserves to be explored, as this can have a prognostic influence in the case of gradual expression demonstrated in the development of (pre) cancerous lesions of the cervix. this study aims to compare the expression of matrix metalloproteinases and their tissue inhibitors between 4 groups of patients defined according to the severity of the cervical lesion.

Eligibility criteria:
inclusion criteria: for control group: * age between 20 and 65 years * patients hospitalized for partial or total removal of the cervix * absence of cervical lesion observed on biopsy or hysterectomy * free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study) * affiliate or beneficiary of a social security scheme for dysplasia and cancer group: * age between 20 and 65 years * cervical intraepithelial neoplasia or previously untreated cervical cancer * free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study) * affiliate or beneficiary of a social security scheme exclusion criteria: for control group: * history of laser or conisation * known antecedent of hiv infection * congenital or acquired immunodepression * long-term treatment with corticosteroids or immunosuppressants * persons placed under the protection of justice for dysplasia and cancer group: * history of laser or conisation * pre-treatment of invasive cancers by radiotherapy or chemotherapy * known antecedent of hiv infection * congenital or acquired immunodepression * long-term treatment with corticosteroids or immunosuppressants * persons placed under the protection of justice

Keywords: matrix metalloproteinases
a modified esophagogastric reconstruction method after laparoscopic proximal gastrectomy

Conditions: Proximal Gastric Adenocarcinoma; Adenocarcinoma of Esophagogastric Junction; Anastomosis

Summary: the double-flap technique (dft) is an effective digestive tract reconstruction method after proximal gastrectomy (pg) to reduce the incidence of postoperative reflux esophagitis. but its clinical application is restricted due to the technical complexity. our surgical team devise a modified esophagogastric reconstructive method which we term the "arch-bridge-type" reconstruction based on the principle of dft. the aim of this single-arm prospective study is to assess the safety and feasibility of the "arch-bridge-type" reconstruction after pg.

1. the lymphadenectomy is performed according to the japanese gastric cancer treatment guidelines. 2. transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor. 3. creating the seromuscular flap ("arch-bridge"): (1) the stomach is resected by a linear stapling device. (2) a "匚" shaped seromuscularflap (3.0cm×4.0cm) is created utilizing electrocautery extracorporeally by dissecting submocosal and muscular layer of the anterior wall of the remnant stomach. (3) the opening of the flap is interrupted sutured by 4-0 absorbable suture, then the "arch-bridge" is created. 4.the remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.

Eligibility criteria:
inclusion criteria: * histologically proven proximal gastric cancer or adenocarcinoma of esophagogastric junction * diameter of the tumor less than 4cm * ecog performance status score ≤2 * no distant metastasis * informed consent is signed exclusion criteria: * metastatic gastric cancer or metastatic adenocarcinoma of esophagogastric junction * remnant gastric cancer * patient requires emergency surgery
study of safety and effectiveness of apidra® in combination with basal insulin in patients with type 1 & 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: primary objectives: to determine the effect of insulin glulisine on glycemic control (hba1c, fbg \& ppbg) from baseline to the end of the study. secondary objectives: to evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the incidence of hypoglycemia and other adverse events.


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes mellitus previously treated for 6 months with prandial insulin + basal insulin or premix (type i) or by either a basal insulin + oad or basal + rhi/other short acting analogue insulin or premix (type ii) with hba1c \>7%. * adequate hepatic and renal functions * ability and willingness of a tight antidiabetic therapy and to perform blood glucose self-monitoring and especially blood glucose profiles, using a blood glucometer at home. exclusion criteria: * pregnant or lactating women or women of childbearing potential not using adequate contraception. * patients with hypersensitivity to insulin glulisine or to any of the excipients. * history of diabetic ketoacidosis. * diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which may require surgical treatment within 3 months of study entry. * alcohol abuse or drug abuse. * clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or psychiatric illness, other serious illnesses, uncontrolled medical conditions or active infections making implementation of the protocol difficult. * medical, psychiatric, or neurologic condition that renders the patient unable to understand the nature and scope of the study. mental retardation or language barrier such that the patient is unable to give informed consent. * participation in an investigational trial within 30 days of study entry. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
adjustable fortification of human milk fed to chinese preterm infants

Conditions: Infant, Premature, Diseases

Summary: this clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.

a total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). the adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (pchm), body weight and blood urea nitrogen (bun). growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and nicu stays will be measured and compared between groups.

Eligibility criteria:
inclusion criteria: * less than 34 weeks gestational age at birth * birth weight within 800-1800 grams * exclusively or mostly breastfed (greater than 80% if the feeding volume) * tolerated enteral feedings of 60 ml/kg/d * remain in the neonatal intensive care unit at least 14 days prior to hospital discharge,remain in the neonatal intensive care unit at least 10 days after enrollment * signed informed consent exclusion criteria: * small for gestational age * infants currently receiving ventilation therapy * major congenital malformations * suspected or documented systemic or congenital infections * evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth * severe intraventricular hemorrhage (greater than grade ii) or periventricular leukomalacia * suspected or documented maternal substance abuse * infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days
evaluation of pain intensity during bone marrow biopsy performed with inhalation of pre-mixed 50 per cent nitrous oxide and oxygen mixture.

Conditions: Pain

Summary: bone marrow biopsy is a painful medical procedure often performed with local anesthetic. therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler

the efficacy of an inhaled equimolar mixture of nitrous oxide and oxygen to prevent procedural pain during lumbar puncture in children has been demonstrated. in adults the use of an inhaled equimolar mixture could prevent pain. although nitrous oxide was initially considered innocuous, evidence began to be gathered later that it had potentially side effect. it has been demonstrated that nitrous oxide inactivates the vitamin b12-dependent enzyme methionine synthetase and impairs dna synthesis in bone marrow cells. therefore this prospective, multicenter randomized placebo controlled, double-blind trial was design to determine whether an inhaled equimolar mixture of nitrous oxide and oxygen would significantly reduce pain during bone marrow biopsy with aspiration. in addition we performed a careful cytological examination of bone marrow samples in order to evaluate the quality of the picture sample.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * with a good clinical condition (score ecog \< 2) * without contra indication for the use of nitrous oxide or previous medical history of allergy to xylocaïne. * informed consent signed up. exclusion criteria: * pregnancy, * prior exposure to nitrous oxide, * patients with neurological illness and those on anti depressant medications or with congestive heart failure or significant respiratory disease. * patients on analgesia for other medical conditions or whose with the inability to provided consent of an assessment of pain. * patients with platelet dysfunction or related coagulation disorders, aspirin or warfarin therapy

Keywords: nitrous oxide and oxygen pain bone marrow biopsy bone marrow aspiration
china intensive lipid lowering with statins in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: in summary, the chillas study will be the first multicenter study performed in a chinese population using a patient-level analysis to compare the effects and safety of intensive statin therapy with that of moderate statin therapy. therefore, it will determine whether "lower is better", that is, whether ldl cholesterol lowering to a level of approximately 100mg/dl provides a benefit inferior to that of ldl cholesterol lowering to a much lower level; examine the role of inflammatory markers in predicting cardiac events and response to statin therapy; and evaluate the effects of statin therapy on regression of coronary atherosclerosis using ivus.

the chillas study is planned to evaluate whether intensive treatment with statins for 2 years results in a reduction of cardiovascular events in patients with acs. a total of 1,600 patients will be randomly assigned to receive intensive statin therapy (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins) or moderate therapy (atorvastatin, 10 mg/d, or equivalent dose of other statins). both groups receive dietary counseling. over a 2-year follow-up period, the primary outcome measure is the time to occurrence of cardiac death, nonfatal acute myocardial infarction, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting, documented unstable angina or severe heart failure requiring emergency hospitalization, and stroke. the planned duration is between december 2006 and december 2009.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute coronary syndrome * clinically stable for 24 hours exclusion criteria: * hypersensitive to statins * receiving therapy with atorvastatin at a dose greater than 20 mg per day before enrollment or lipid-lowering therapy with fibric acid derivatives or niacin that can not be discontinued * having a coexisting condition that shortened expected survival to less than two years * having obstructive hepatobiliary disease or other serious hepatic or kidney disease * having an unexplained elevation in the creatine kinase level that was more than three times the upper limit of normal and that was not related to myocardial infarction * having undergone surgery or serious trauma within the preceding two months * having been in the final stage of chronic congestive heart failure * having a baseline level of ldl cholesterol less than 50mg/dl

Keywords: acute coronary syndrome intensive lipid-lowering statins